|Publication number||US7771412 B2|
|Application number||US 11/874,776|
|Publication date||Aug 10, 2010|
|Filing date||Oct 18, 2007|
|Priority date||Oct 18, 2006|
|Also published as||US20080116647|
|Publication number||11874776, 874776, US 7771412 B2, US 7771412B2, US-B2-7771412, US7771412 B2, US7771412B2|
|Inventors||Marc Anderson, John Garibotto, Steven Dilanni|
|Original Assignee||Insulet Corporation|
|Export Citation||BiBTeX, EndNote, RefMan|
|Patent Citations (22), Referenced by (19), Classifications (11), Legal Events (2)|
|External Links: USPTO, USPTO Assignment, Espacenet|
The present application claims the benefit of U.S. Provisional Patent Application Ser. No. 60/829,984 filed Oct. 18, 2006, which is fully incorporated herein by reference.
The present invention relates to fluid delivery devices and more particularly, to an environmental seal in the fluid pathway of a fluid delivery device.
Among fluid delivery devices, especially for medical applications, there is often a need to provide an environmental seal around a fluid pathway as it passes from one environment to another and/or where one cannula portion is joined to another. Such an environmental seal might, for example, serve to exclude water from the interior of a device, such as an infusion pump. Such an environmental seal might also serve to exclude the passage of air from one environment to another to limit the transmission of microorganisms from one environment to another, or to maintain the integrity of the fluid pathway at the junction between two cannulas forming the pathway. It is well known to create such an environmental seal by inserting a pierceable membrane in a carrier element. However, since it is often desirable to make medical devices as small as possible, there is a corresponding need to make an environmental seal as small as possible without compromising the quality and reliability of the seal. Further, since such seals may be useful in devices that are intended to have short useful lives, it is also desirable to manufacture such devices at the lowest possible cost. Unfortunately, known methods for assembling environmental seals are not well suited for miniaturization with high quality and reliability and low cost.
These and other features and advantages will be better understood by reading the following detailed description, taken together with the drawings wherein:
The cap 110 also comprises a plug 114. The plug 114 may be formed of silicone, preferably having a durometer from about 5-15 SHORE A, most preferably 10 SHORE A. The plug 114 is preferably formed from a medical grade silicone and may be a bondable silicone. The plug 114 completely obstructs a portion of the channel 116. The plug 114 may be formed in the cavity 126 of the carrier 112. The cap 110 is preferably formed by a 2-shot molding process in which the carrier portion 112 comprises the first shot and the plug portion 114 comprises the second shot. The cap 110 may also be formed by molding the carrier 112 and pot curing the plug 114 in the carrier 112. The carrier 112 may contain one or more secondary channels (not shown) in which the silicone may be injection molded or pot cured and which serve to secure the plug 114 to the carrier 112.
The environmental seal 100 may also comprise a cap receptacle 140 that receives the cap 110 and applies a compressive force to a portion of the circumference of the cap 110. The cap receptacle 140 is adapted to mate with the cap 110. The cap receptacle 140 is a solid having proximal and distal ends 142, 144 and a channel 146 extending through the cap receptacle 140 from the proximal end 142 to the distal end 144. The proximal end 142 of the cap receptacle 140 comprises an outer sleeve portion 150 adapted to mate with the inner sleeve portion 124 of the cap 110 and to apply a compressive force to the inner sleeve portion 124 and the plug 114. The outer sleeve 150 of the cap receptacle 140 may be tapered to mate with the tapered sleeve 124 of the cap 110. Preferably, when the cap 110 and cap receptacle 140 are assembled, the plug 114, the inner sleeve 124 and the outer sleeve 150 are generally concentric cylinders.
When the cap 110 and cap receptacle 140 are assembled, the outer sleeve 150 of the cap receptacle 140 applies sufficient compression to the inner sleeve 124 of the cap 110 and plug 114 to create a fluid impervious seal around the cannula 102 while permitting movement of the cannula 102 through the plug 114 and the channel 116, as described below. In one embodiment, when the cap 110 and cap receptacle 140 are assembled, the outer sleeve 150 of the cap receptacle 140 applies sufficient compression to the inner sleeve 124 of the cap 110 and plug 114 to displace at least about 5% of the volume of the plug 114. Notably, since the plug 114 is made of silicone, it does not compress, but portions of the cap 110 are displaced to fill gaps between the cap 110 and cap receptacle 140 and thereby form a seal. The cap receptacle 140 may be integrated into a separate body. For example, the cap receptacle may be feature molded in the housing of an infusion pump (not shown).
The environmental seal 100 may also comprise a cannula 102 or similar structure passing through the channel 116 from the proximal end to the distal end and through the plug 114. When the cap 110, cap receptacle 140 and cannula 102 are assembled, the cannula 102 preferably can move relatively easily along the axis of the channel 116 through the plug 114, but the plug 114 forms a seal around the cannula 102 to exclude water and air from crossing from the distal to the proximal end of the environmental seal, or vice versa. The cannula 102 may be a single cannula or may comprise multiple lumens. In one embodiment, the cannula comprises a relatively stiff introducer needle surrounded by a flexible soft cannula.
Another embodiment of an environmental seal 500, shown in
The nozzle cap 510 comprises a carrier 512 and a plug 514. The carrier 512 is preferably a relatively high durometer molded plastic component having a solid form and a channel 516 through the solid. The carrier portion 512 of the cap 510 may have a cylindrical shape with the channel 516 passing from the proximal end 520 to the distal end 522 of the carrier 512. The distal end 522 of the carrier 512 may comprise a sleeve portion 524 surrounding the plug 514. The sleeve portion 524 preferably defines a widened area of the channel 516 forming a cavity 528 at the distal end of the carrier 512. The walls of the sleeve 524 may be tapered or contain other physical features to facilitate the cap mating with the nozzle boss 542 described below.
The cap 510 also comprises a plug 514. The plug 514 may be formed of silicone, preferably having a durometer from about 5-15 SHORE A, most preferably 10 SHORE A. The plug 514 completely obstructs a narrow portion of the channel 516, but, unlike the embodiment of
The environmental seal 500 also comprises a nozzle 540 and nozzle boss 542. The proximal end of the nozzle 540 is adapted to mate with the plug 514 and the nozzle boss 542 respectively. The distal end of the nozzle 540 is adapted to mate with the proximal end of the distal cannula 504, thereby securing the distal cannula 504 to the nozzle boss 542. The nozzle 540, as well as the proximal and distal cannulas 502, 504, are preferably made with a material that is compatible with the substance to be transferred through the cannulas 502, 504 and nozzle 540. In one embodiment, the nozzle 540 and proximal cannula 502 are made from stainless steel and the distal cannula 504 is made from fluorinated ethylene propylene.
As noted above, the nozzle boss 542 receives the distal cannula 504 and the nozzle 540. The proximal end of the nozzle boss 542 comprises a sleeve 544 adapted to mate with the inner walls of the sleeve 524 of the nozzle cap 510 such that the nozzle cap sleeve 524 applies a compressive force to the nozzle boss sleeve 544 and the plug 514 sufficient to cause the plug 514 to form a seal with the nozzle 540, nozzle boss 542 and nozzle cap carrier 512, but not so great as to inhibit movement of the proximal cannula 502 through the plug 514 along the axis of the channel 516. In one embodiment, when the nozzle cap 510, nozzle 540 and nozzle boss 542 are assembled, the nozzle cap sleeve 524 applies sufficient compression to the nozzle boss sleeve 544, and, thereby, the plug 514 to displace at least about 5% of the volume of the plug 514.
In an embodiment, the environmental seal 500 is part of cannula insertion system in which the proximal cannula 502 is held by a first moveable carrier (not shown) and the distal cannula 504 is received in the nozzle boss 542, which is held by a second moveable carrier (not shown). In use, the first and second carriers may be advanced to an advanced position such that the proximal and distal cannulas 502, 504 are advanced together to a desired position, such as a desired subcutaneous depth. Thereafter, the second moveable carrier is moved proximally thereby withdrawing the proximal cannula 502 a selected proximal distance. In this process, the proximal cannula 502 moves freely through the plug along the axis of the channel 516 without compromising the seal between the nozzle cap 510, plug 514, nozzle 540 and nozzle boss 542 so that there is no leakage into or out of the fluid pathway formed by the proximal and distal cannulas 502, 504 and the nozzle boss 542.
Accordingly, the environment seal, consistent with embodiments of the present invention, is capable of sealing a fluid pathway in a fluid delivery device while being relatively small and produced in accordance with relatively tight specifications and at relatively low cost.
While the principles of the invention have been described herein, it is to be understood by those skilled in the art that this description is made only by way of example and not as a limitation as to the scope of the invention. Other embodiments are contemplated within the scope of the present invention in addition to the exemplary embodiments shown and described herein. Modifications and substitutions by one of ordinary skill in the art are considered to be within the scope of the present invention, which is not to be limited except by the following claims.
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|Cooperative Classification||A61M39/06, A61M2039/066, A61M39/20, A61M39/04, F16L5/10|
|European Classification||A61M39/04, A61M39/06, A61M39/20, F16L5/10|
|Feb 8, 2008||AS||Assignment|
Owner name: INSULET CORPORATION, MASSACHUSETTS
Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNORS:ANDERSON, MARC;GARIBOTTO, JOHN;DILANNI, STEVEN;REEL/FRAME:020481/0312;SIGNING DATES FROM 20080124 TO 20080125
Owner name: INSULET CORPORATION, MASSACHUSETTS
Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNORS:ANDERSON, MARC;GARIBOTTO, JOHN;DILANNI, STEVEN;SIGNING DATES FROM 20080124 TO 20080125;REEL/FRAME:020481/0312
|Feb 10, 2014||FPAY||Fee payment|
Year of fee payment: 4